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Staff Validation Engineer

Integrated Resources, Inc

Greenville, NC

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JOB DETAILS
JOB TYPE
Contractor
SKILLS
Best Practices, Biotech and Pharmaceutical, Communication Skills, Cost Control, Customer/Client Research, Data Analysis, Data Quality, Database Administration, Database Programming, Identify Issues, Industry Standards, Interpersonal Skills, Management Consulting, Manufacturing, Manufacturing Assembly, Manufacturing Equipment, Manufacturing/Industrial Processes, Mathematics, Metrics, Microsoft Office, Performance Testing, Presentation/Verbal Skills, Problem Solving Skills, Procedure Development, Quality Assurance Methodology, Quality Engineering, Regulations, Reporting Dashboards, Risk, Root Cause Analysis, Schematics, Statistical Sampling, Statistics, Strategic Planning, System Validation, Testing, Time Management, Validation Documentation, Validation Plan, Validation Testing, Writing Skills
LOCATION
Greenville, NC
POSTED
30 days ago
Job Title: Staff Validation Engineer Job Location: Greenville, NC Job Duration: 12 Months (possibility of extension) Job Summary: The Staff Validation Engineer will oversee development and execution of validation master plans and identify approaches based on risk. The Validation Engineer will also oversee other Validation Engineers and consultants as well as develop, scale up, optimize, evaluate, and calibrate equipment, systems, and write procedures and protocols. The Validation Engineer will also manage timelines, metrics, Product, and site reporting requirements. This position will demonstrate complete understanding of validation related activities to independently manage the strategy around increasingly complex projects. Key Responsibilities: Independently manages other validation engineers and/or consultants, tracks overall validation master plan progress and provides dashboard updates to senior management. Consults with management, assesses customer requirements, and studies product characteristics to select validation objectives and standards. Develops validation strategies and approaches consistent with all applicable site guidance documents and writes protocols for validation or performance testing of manufacturing equipment, processes, or systems. Applies current validation best practices and knowledge of risk-based validation approaches across a wide range of manufacturing sub-assembly and assembly processes. Executes qualifications and validations as needed. Analyzes data from validation tests to determine whether systems and processes meet required criteria and specifications. Collaborates and coordinates with appropriate departments and staff regarding the scheduling or implementation of validation testing. Identifies root causes of production problems. Identifies nonconformities of product or process standard and offers recommendations for resolving deviations. Develops and maintains databases for tracking test results, validation activities, or validated systems. Develops, maintains, or reviews validation and compliance documentation including schematics, protocols, and engineering change notices. Modifies testing methods or revisits test objectives and standards to resolve testing problems. Calibrates equipment to ensure accurate measurements. Performs other related duties as assigned. Identifies scale up and cost savings opportunities and directly plans and supports scale up, optimization, and development of new manufacturing processes. Minimum Requirements/Qualifications: Bachelor’s degree in related field required. 11-15 years of experience in biotech manufacturing, quality, engineering, or validation required. Personal Attributes: Excellent verbal and written communication skills required. Excellent interpersonal skills required. Thorough understanding of industry standards and regulatory guidelines. Thorough understanding of applicable mathematics and scientific practices including statistical sampling plans and statistical and data analysis. Thorough understanding of related equipment and the ability to perform equipment modifications. Proficient with Microsoft Office Suite or related software.

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Integrated Resources, Inc

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